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120 Eating Disorder Trials
Power is an online platform that helps thousands of Eating Disorder patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Solriamfetol for Binge Eating Disorder
Overland Park, KansasThis is a Phase 3, multi-center, open-label study to evaluate the long-term safety and efficacy of solriamfetol in the treatment of binge eating disorder (BED) in adults.
No Placebo Group
Pivotal Trial
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 3
Age:18 - 56
Sex:All
300 Participants Needed
Solriamfetol for Binge Eating Disorder
Overland Park, KansasENGAGE (Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol) is a Phase 3, randomized, double-blind, placebo-controlled, multicenter trial to assess the efficacy and safety of solriamfetol for the treatment of binge eating disorder (BED) in adults.
Pivotal Trial
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:18 - 55
Sex:All
Key Eligibility Criteria
Disqualifiers:Prior Solriamfetol Exposure, Others
450 Participants Needed
Megestrol for Feeding Disorders in Children
Kansas City, MissouriThis is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:9+
Sex:All
71 Participants Needed
Focused Acceptance and Commitment Therapy for Parental Mental Health
Kansas City, MissouriThis is a randomized clinical trial of Focused Acceptance and Commitment Therapy (FACT) vs. an attention-control condition (placebo) for improving the mental health of parents of children with pediatric feeding disorder.
The goal of this clinical trial is to compare two programs in parents of children with pediatric feeding disorders.
The main question\[s\] it aims to answer are:
FACT will result in clinically meaningful reductions in Mental Health(MH) problems among parents of children with Pediatric Feed Disorder (PFD) Identify factors that impact the feasibility of FACT delivery
Participants will asked to participate in one of two programs focused on parents of children with pediatric feeding disorders. The participants will also be asked to complete a battery of questionnaires at four timepoints during the study. The parents will be asked to video record a meal time three times during study.
Researchers will compare the FACT group with a control group to see if FACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Cognitive Impairments, Non-English Speakers, No Internet
80 Participants Needed
Parent Acceptance and Commitment Therapy for Pediatric Feeding Disorder
Kansas City, MissouriThis is a pilot study of randomized clinical trial of Parent Acceptance and Commitment Therapy (PACT) vs. an attention-control condition (placebo) for improving the mental health of parents of children with pediatric feeding disorder.
The goal of this clinical trial is to compare two programs in parents of children with pediatric feeding disorders.
The main question\[s\] it aims to answer are:
* PACT will result in clinically meaningful reductions in Mental Health(MH) problems among parents of children with Pediatric Feed Disorder (PFD)
* Identify factors that impact the feasibility of PACT delivery
* Participants will asked to participate in one of two programs focused on parents of children with pediatric feeding disorders.
* The participants will also be asked to complete a battery of questionnaires at four timepoints during the study.
* The parents will be asked to video record a meal time twice during study.
If there is a comparison group: Researchers will compare the PACT group with a control group to see if PACT will result in clinically meaningful change in parent stress and anxiety, and parent use of positive mealtime behaviors.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 99
Sex:All
73 Participants Needed
Naltrexone for Eating Disorders
Kansas City, MissouriThis trial tests if brain scans can show how naltrexone affects the brain in adolescents with binge/purge eating disorders. Naltrexone may help reduce harmful eating behaviors. Naltrexone is a well-tolerated drug used to help with behaviors like substance use, obesity, and eating disorders.
Trial Details
Trial Status:Recruiting
Trial Phase:Early Phase 1
Age:13 - 21
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Metal Implants, Language Barrier, Others
Must Not Be Taking:Naltrexone, Opioids
60 Participants Needed
Wakaya Program for Childhood Obesity
Talihina, OklahomaInvestigators will conduct a two-group randomized waitlist-control trial to assess the efficacy of the Wakaya: Rising Up for Choctaw Youth Health program on improving physical activity, reducing sedentary behaviors and improving healthful eating habits as well as delaying or reducing alcohol, tobacco and other drug use. Wakaya is an experiential, outdoor, nature-based program grounded in Choctaw values. It is a multi-level intervention that increases individual motivation and leadership skills to make healthy behavioral choices for behavior and exercise.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:12 - 19
Sex:All
Key Eligibility Criteria
Disqualifiers:Opioid Use, Methamphetamine Use, Allergies, Disability, Aggressive Behavior, Others
176 Participants Needed
Social Therapy for Eating Disorders
Dallas, TexasSocial processing and cognition are often altered in patients with eating disorders. The goal of this clinical trial is to assess two different social therapeutic interventions -- one educational, one interactive -- for their effectiveness in improving clinical outcomes in patients with eating disorders. Patients in both interventions will receive education about social function in eating disorders, but those in the interactive treatment group will complete an additional collaborative art task.
Participants will:
* attend a baseline study visit to complete clinical interviews, cognitive testing, and behavioral tasks
* complete a pre-intervention assessment with questionnaires
* attend eight sessions of their assigned treatment group over the course of 12 weeks
* complete three virtual follow-up assessments 4, 8, and 12 months from their baseline
* attend a final study visit to repeat some clinical interviews, cognitive testing, and behavioral tasks
Researchers will compare changes in eating disorder, mood, and anxiety symptoms as well as test results from baseline and final study visits for each group to see if
* patients can be treated effectively with education alone or if an interactive group component produces additional benefits
* cognitive and behavioral task performance are associated with recovery or illness state.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 30
Sex:All
Key Eligibility Criteria
Disqualifiers:Inpatient Treatment, Medical Instability, Others
60 Participants Needed
BEET Program + CBT for Type 2 Diabetes and Eating Disorders
Aurora, ColoradoDisordered eating behaviors (DEBs, e.g., binge eating or restrictive eating) can significantly impact type 2 diabetes (T2D) self-management and engagement in treatment for diabetes. Managing DEBs is a treatment component in diabetes self-management; however, it is not often the primary focus, and trained behavioral health providers are inconsistently involved in comprehensive diabetes management. This study plans to pilot two behavior change programs for disordered eating in T2D and gather information on factors that predict successful adoption and implementation in real-world clinical settings.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:18 - 65
Sex:All
80 Participants Needed
Expectancy Challenge Intervention for Indigestion
Laramie, WyomingThis study aims to create and test an intervention that helps college students re-evaluate their beliefs about food and alcohol disturbance (FAD) and, in turn, reduce how often they engage in it or intend to in the future. The main questions it aims to answer are:
1. Does the intervention help students have less positive beliefs about the effects of FAD and more negative beliefs about its effects?
2. If college students' beliefs about FAD change, does that lead them to engage in it less often or plan to do it less?
3. Will college students who engage in FAD sign up for the study, complete it, and feel that the intervention is helpful and valuable?
Participants will take part in one 2-hour in-person laboratory-based study session where they will fill out surveys, learn about FAD, and engage in exercises designed to challenge their existing beliefs about it. They will also complete a follow-up survey online one month after their in-person study visit.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 25
Sex:All
75 Participants Needed
Weighted Blanket for Picky Eating Anxiety
Austin, TexasThis small experimental pilot study addresses the knowledge gap related to the use of weighted blankets for children with anxiety related to food and eating.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:8 - 12
Sex:All
Key Eligibility Criteria
Disqualifiers:Spinal Cord Injury, Cerebral Palsy, Others
12 Participants Needed
Family-Based Treatment for Eating Disorders
Rochester, MinnesotaThis trial tests a new family-involved treatment for young people with eating disorders, delivered by regular doctors. It aims to make effective care more accessible and help parents support their child's recovery.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:7 - 18
Sex:All
200 Participants Needed
HRV-bio + ED-JITAI for Eating Disorder
Minneapolis, MinnesotaThe present study will be fully remote (virtual) and include observational design features (assessments) plus a clinical trial. All assessments will be completed using HIPAA-approved platforms (e.g., Qualtrics, MindLogger EMA platform). After screening via Qualtrics to determine eligibility (described below), participants will complete a cross-sectional survey via Qualtrics, followed by a baseline EMA period. During the baseline EMA period, participants will receive brief (3-5 minutes) surveys on their mobile devices 6 times per day for 7-days via the MindLogger app. During the baseline EMA period, participants will also be asked to wear non-invasive chest-worn Holter monitors (Polar H10 Holter monitors) that will capture their heartrate variability data.
They will then complete the 4-week intervention (HRV bio or ED-JITAI treatment arms; see below), followed by a post-intervention 7-day EMA assessment period while they also wear the Holter monitors. Recruitment is expected to last for 1.5 years. In HRV-bio, participants will also complete a HRV biofeedback task via the Elite HRV app. In this intervention, participants will learn how to use their HRV data that they will see in real-time via the Elite HRV app to improve their HRV by engaging in an app-guided diaphragmatic breathing exercise. They will complete this exercise twice daily (morning, night). In ED-JITAI, participants will be prompted to complete focused, guided body scan tasks that will be sent to them via the MindLogger app. These guided tasks will be sent to them in the form of 1 of 3 brief (3-5 minute) videos via the MindLogger app. The body scans will be designed to promote participants' connection with, vs.
distancing/distraction from, feared ED sensations (e.g., hunger, satiety, bloating).
Participants will receive prompts to complete the body scans at times when they report via EMA that they are experiencing worse interoception than usual. "Worse interoception than usual" will be defined as participants' EMA-reported interoception scores during the intervention period that fall 1 SD or more above their baseline EMA-reported interoception levels.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Sex:All
Key Eligibility Criteria
Disqualifiers:Age, ED Treatment Changes, Bariatric, Pregnancy, Others
144 Participants Needed
Brain Stimulation + Cognitive Training for Anorexia
Minneapolis, MinnesotaThis study looks at adults with restrictive eating disorders who are currently receiving outpatient treatment for their eating disorder to examine whether a new brain stimulation technique called non-invasive transcranial direct current stimulation (tDCS) can enhance brain training. Participation involves interviews, assessments, 10 sessions of brain stimulation (active or sham), and computerized brain training over a 3-4 week period, with one post-intervention visit, and one 1-month follow-up visit.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Substance Abuse, Neurological Condition, Serious Psychiatric Disorder, Medical Instability, TDCS Contraindication, Others
20 Participants Needed
Exercise Response for Eating Disorders
Madison, WisconsinIndividuals with eating disorders (ED) represent a high-priority clinical population, with among the highest mortality rates of any psychiatric disorder, and driven exercise (DEx) is a symptom evidenced in up to 80% of those with EDs that increases impairment and negatively impacts treatment outcome. This study will develop tasks to characterize cognitive, affective, and biological response to exercise among adolescent and young adult females with EDs and determine whether acute exercise response associates with free-living activity and DEx. This R21 project will provide foundational data to guide research and development of treatments that are more precisely targeted to the symptom of driven exercise and to ultimately improve clinical outcomes associated with EDs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:16 - 25
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychotic Disorders, Intellectual Disabilities, Pregnancy, Others
Must Not Be Taking:Psychiatric Medications, Sedatives, Pain Killers, Stimulants
100 Participants Needed
Nutrition Education Program for Childhood Obesity
Houston, TexasTo assess feasibility and acceptability of of integrating Food Rx and Best Feeding Practices with EFNEP participants via a pilot study.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 64
Sex:All
Key Eligibility Criteria
Disqualifiers:Children With Disabilities, Others
Must Not Be Taking:Weight Medications
30 Participants Needed
Virtual Intervention for Binge Eating Disorder
Chicago, IllinoisThe aim of this project is to pilot test a novel mobile app intervention for adolescents with dysregulated eating behaviors and elevated weight status. This intervention will incorporate evidence-informed strategies targeting self-regulation into cognitive-behavioral treatment for maladaptive eating. Adolescents will use the app for 16 weeks and provide feedback on its usability and effectiveness in managing dysregulated eating.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:13 - 19
Sex:All
Key Eligibility Criteria
Disqualifiers:Diabetes, Bulimia Nervosa, Others
Must Not Be Taking:Weight Medications
140 Participants Needed
Nutrition Education for Healthy Eating and Food Security
West Lafayette, IndianaFood insecurity and low diet quality are persistent problems linked with chronic disease and poor health among limited-resource children and adults using Supplemental Nutrition Assistance Program (SNAP). We have shown nutrition education via adult-focused, direct SNAP-Education (SNAP-Ed) improved household food security by 25% but not adult dietary quality among SNAP-eligible households using a randomized, controlled, longitudinal SNAP-Ed intervention in Indiana. Households experiencing food insecurity often reserve food considered "healthful" for children, so child dietary quality improvement may precede that observed among adults when household food security improves. This study will determine the effect of adult-focused direct SNAP-Ed on child dietary quality and household food security using a longitudinal randomized, controlled SNAP-Ed intervention. Assessment will include repeated 24-hour dietary recalls to determine usual intake, the U.S. Household Food Security Survey Module, and behavior data from before and after the 10-week "intervention period," and 1 year later, after which the control group will receive the intervention. Low-income participants (n=275) from Indiana will be recruited following SNAP-Ed protocol. Results of the study will inform the creation of supplementary on-demand SNAP-Ed educational material focused on improving healthful dietary intake for children and adults in situations of food insecurity in households with children. Education on modeling healthy attitudes and behaviors, planning and preparing family meals, and dietary shortfalls as informed by the results and previous evidence will be included and evaluated. The study aligns with the goals of USDA to increase food security and this RFP to improve healthful behaviors, food quality and nutrition.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:5+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, Lactation, Others
300 Participants Needed
Assistive Technology for Children on Tube Feeding
Chicago, IllinoisThe overall objective of this proposal is to test an interdisciplinary intervention to support the transition to oral feeding for children with feeding tubes and tracheostomies. The investigators' model which combines in-home clinical assessments with virtual therapies may maximize the impact of expert interventionists. The investigators' central hypothesis is that children with feeding tubes and tracheostomies will have greater success than a control group when enrolled in a hybrid in-person/virtual intervention including: (1) a coordinated feeding team with an occupational therapist, speech/language pathologist, and registered dietitian; (2) family liaison study coordinators who are poised to support the family through personal experience; (3) a project leader who is a Developmental Behavioral Pediatrician with expertise in children with tracheostomies. The overall objective of this proposal is to test this intervention to increase oral feeding in children with feeding tubes and tracheostomies. To pursue this objective, the investigators propose the following aims:
Specific Aim 1: Children enrolled in the intervention group will have improved caregiver self-efficacy and reduced worry related to feeding as determined by The Feeding and Swallowing Impact Survey at the end of a 1-year intervention.
Specific Aim 2: Children enrolled in the intervention group will have increased oral vs. tube-fed calories and reduced dependence on feeding tubes as determined by detailed dietary histories and The Children's Eating and Drinking Activity Scale (CEDAS) at the end of a 1-year intervention.
The investigators' intervention will determine if a tertiary center of expertise can use a combination of home assessments and virtual interventions to address critical feeding needs for children with tracheostomies. Future clinicians could refer patients to the investigators' center instead of relying on community therapists, who rarely exist.
The weekly feeding group sessions as well as the administration of the therapies in a virtual format are research-related. While the therapy techniques implemented during the study are standard of care and within the practice parameters of the practitioners involved, the use of them in a virtual format are novel and should be considered research-related.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:< 3
Sex:All
Key Eligibility Criteria
Disqualifiers:Wards Of The State
40 Participants Needed
Project YES for Depression and Anxiety
Chicago, IllinoisThis study tests a suite of single-session intervention (SSI) targeting risk factors for depression and eating disorders among adolescents and young adults. Youth ages 13-25 who screen positive for depression or anxiety as a part of routine care will be offered one of three digital SSIs. Participants will complete questionnaires before the intervention, immediately after the intervention, and 3-months after completing the intervention so that the study team can investigate if Project YES leads to reductions in depression, anxiety and eating disorder symptoms.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Unphased
Age:13 - 25
Sex:All
100 Participants Needed
Behavioral Intervention for Binge Eating
Chicago, IllinoisThe purpose of this study is to conduct a micro-randomized trial to learn which evidence-based targets within a mobile intervention for binge eating and weight-related behaviors are most impactful for which people and in what sequence.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
Key Eligibility Criteria
Disqualifiers:Pregnancy, No Clinical Services, Others
300 Participants Needed
Whole Foods Diet for Prediabetes
Nashville, TennesseeThis study will address the following aims:
Aim 1 (primary): Conduct a pilot RCT to evaluate the feasibility, acceptability, enrollment, and retention rates of adult-child pairs after a 12-week family-centered, non-calorie restricted whole foods diet.
Feasibility: ≥80% participant retention and completion of study outcome measures.
Acceptability: ≥75 adult diet satisfaction via survey report and/or perceived diet satisfaction via focus groups. Aim 2: Conduct a pilot RCT to evaluate the preliminary effectiveness of a non-calorie restricted whole foods diet on adult HbA1c at 12 weeks and adult/child diet quality during the 12-week intervention.
Aim 2a: Evaluate intervention effects on HbA1c measures in adults with prediabetes.
Hypothesis 2a: Adults randomized to the treatment group will have lower HbA1c measures at 12 weeks than those in the control group.
Aim 2b: Evaluate intervention effects on the diet quality (via the 2020 HEI) of adults and children. Hypothesis 2b: Adults and children randomized to the treatment group will have a higher diet quality score during the 12-week intervention period compared to adults and children in the control group.
Aim 3: Conduct family focus groups to understand how SDOH and individual/family needs and preferences may be perceived barriers or facilitators of diet adherence.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:6 - 59
Sex:All
30 Participants Needed
Self-Guided Personalized Treatment for Eating Disorders
Louisville, KentuckyThe investigators plan to collect preliminary data on the feasibility, acceptability, and user uptake of a personalized self-guided mobile intervention for disordered eating (DE) and test the initial clinical efficacy of this intervention. Women (N=50) who endorse significant DE will complete two weeks of smart-phone self-monitoring to identify target problems and will be sent two self-guided modules of personalized treatment directly to their smart-phones. The investigators will assess engagement with the modules throughout two months and administer baseline, week 5, and week 8 assessments for acceptability, uptake, and initial clinical efficacy (e.g., DE symptoms, anxiety, quality of life). The investigators will also complete a focus group (n=10) with a subset of users to receive input on the mobile-application assessment and ease of self-guided intervention modules.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
50 Participants Needed
RISE Therapy for Eating Disorders
Louisville, KentuckyInteroception is the process of perceiving one's bodily sensations. Interoception is critical for survival and maintaining homeostasis, as it motivates sensation- and need-specific autonomic reflexes and adaptive behaviors (e.g., eating when hungry, terminating eating upon fullness, drinking when thirsty). Not all individuals have accurate interoceptive abilities. Individuals with eating disorders often have low perception of gastrointestinal, pain, and emotion sensations. Interoceptive dysfunction is believed to influence the development and maintenance of many forms of psychopathology. Identifying effective ways to restore accurate interoceptive processing is an important aim for clinical researchers. The goal of the present study is to continue to test the effectiveness of a training for interoceptive dysfunction that aims to reconnect individuals with eating disorders with their internal sensations, which is called, Reconnecting to Internal Sensations.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:10 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Under Age 10
50 Participants Needed
Online Relapse Prevention Methods for Eating Disorders
Louisville, KentuckyThe purpose of this study is to collect preliminary data on the feasibility and acceptability of the randomization of two relapse-prevention treatment conditions after discharge from intensive eating disorder (ED) treatment: an imaginal exposure therapy and a writing and thinking intervention. The second aim to test for (a) differences between the two treatments for the prevention of relapse and (b) preliminary change on clinical ED outcomes (e.g., ED symptoms, fears). The investigators further aim to examine the two treatments target fear extinction and if fear extinction is associated with ED outcomes. The investigators also plan to test if baseline differences in fear conditioning relate to change in ED outcomes across treatment.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
130 Participants Needed
Rumination-Focused Cognitive Behavioral Therapy for Depression
Louisville, KentuckyMany people know that a poor diet, exercise, smoking, and alcohol use cause heart disease. However, a less known factor that increases the risk of heart disease is depression. In addition, heart disease can also make depression worse. Almost half of American adults have some form of heart disease. Patients with low income are at an even greater risk. The circular relation between depression and heart disease raises the question of whether or not there are factors that lead to both. Attacking a factor that affects both depression and heart disease could help prevent them both. One such factor is rumination which is when someone tends to have repeated negative thoughts that loop without end. This loop in turn tears and wears down the body over time, making the person be at risk for heart disease and depression. Rumination-Focused Cognitive Behavioral Therapy (RFCBT) is a tool that targets rumination and, by doing so, reduces the risk for depression. While research has shown RFCBT helps to reduce or stop the loop that leads to depression, this project will further look at the effect of RFCBT on measures of heart health persons with low income.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
9 Participants Needed
Plant-Based Diet for Healthy Eating Habits
Louisville, KentuckyThe investigator's goal is to promote a plant-based diet amongst the underserved urban population of Louisville with the help of educational aids and the provision of affordable resources.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18+
Sex:All
300 Participants Needed
Personalized Treatment for Eating Disorders
Louisville, KentuckyEating disorders (EDs) are serious mental illness: someone dies of an ED every 52 minutes. EDs are highly related to a host of negative outcomes, including public health and individual disease burden, medical and psychological comorbidities, and social determinants of health (SDOH). Treatment response for EDs are suboptimal; there are no evidence-based treatment for adults with anorexia nervosa (AN) or Other Specified Feeding or Eating Disorder (OSFED) and only 50% of adults respond to current evidence based treatments. There are no precision treatments, nor any treatments that consider social context, in existence. Personalized treatments for EDs, that consider social contexts, are urgently needed to improve treatment response and minimize the suffering associated with these illnesses. The investigators' overall goal, extending upon their past work, is to create a treatment personalized based on idiographic (or one person) models (termed Transdiagnostic Network Informed Personalized Treatment for EDs; T-NIPT-ED). The investigators will carry out a two-phase study to systematically characterize individual mechanisms of treatment (Phase I: N=900) and then test the efficacy of each treatment module (Phase II: N=240 drawn from Phase I) compared to the current gold-standard treatment (Cognitive Behavioral Therapy Enhanced: CBT-E). The study goals are to (1) characterize the prevalence of T-NIPT-ED precision treatment mechanisms and medical and psychological comorbidities (e.g., obesity; depression), individual disease burden (e.g., disability), SDOH (e.g., food insecurity), and public health outcomes (e.g., service utilization) specific to these mechanisms, (2) identify if personalized target mechanisms improve when matched to evidence-based treatment modules of T-NIPT-ED and (3) test if change in T-NIPT-ED is associated with improved outcomes (vs CBT-E), including ED outcomes, comorbidities, disease burden, and public health outcomes and if these outcomes are moderated by SDOH. These goals will ultimately lead to the very first precision treatment for ED and can be extended to additional psychiatric illnesses. The proposed research uses highly innovative methods; intensive longitudinal data collected with mobile technology is combined with state-of-the art idiographic modeling methods to deliver a virtual, personalized treatment. This proposal integrates assessment of broad (e.g., SDOH; public health burden) and specific (e.g., ED symptoms) outcomes, to ensure that social context can be integrated into personalization. The proposed research has high clinical impact. Ultimately, this proposal will lead directly to the creation and dissemination of an evidence-based individually-personalized treatment for EDs, as well as will serve as an exemplar for precision treatment development across the entire field of psychiatry.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
Key Eligibility Criteria
Disqualifiers:Active Suicidality, Active Mania, Active Psychosis
320 Participants Needed
Personalized Treatment vs Cognitive Behavioral Therapy for Eating Disorders
Louisville, KentuckyThe scientific premise, developed from past work, is that treatment personalized based on idiographic models (termed Network Informed Personalized Treatment; NA-PT) will outperform the current gold-standard treatment (Enhanced Cognitive Behavioral Therapy: CBT-E). The study goals are to (1) develop and test the acceptability, feasibility, and preliminary efficacy of a randomization of NA-PT versus CBT-E and (2) to test if network-identified precision targets are the mechanism of change. These goals will ultimately lead to the very first personalized treatment for ED and can be extended to additional psychiatric illnesses. Specific aims are (1) To collect preliminary data on the feasibility and acceptability of the randomization of NA-PT (n=40) for EDs versus CBT-E (n=40), (2) To test the initial clinical efficacy of NA-PT versus CBT-E on clinical outcomes (e.g., ED symptoms, body mass index, quality of life) and (3) To examine if changes in NA-identified, precision targets, as well as in dynamic network structure, are associated with change in clinical outcomes.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
80 Participants Needed
Facing Eating Disorder Fears for Anorexia Nervosa
Louisville, KentuckyThis trial tests a therapy called FED-F that helps people with Anorexia Nervosa face their fears about food, weight, and social situations. The goal is to see if this approach can reduce anxiety and prevent relapse by encouraging patients to confront their fears.
Stay on current meds
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Age:18 - 65
Sex:All
70 Participants Needed
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Frequently Asked Questions
How much do Eating Disorder clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Eating Disorder clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Eating Disorder trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Eating Disorder is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Eating Disorder medical study ?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Eating Disorder clinical trials ?
Most recently, we added Online Intervention for Sustainable Eating, Digital Intervention for Binge Eating Disorder in Black Women and Appetite Awareness Training + Diabetes Prevention for Type 2 Diabetes to the Power online platform.